Today is 2020-07-05

Decellular neuromatrix repair membranes for prospective, randomized, single-blind, parallel controlled trial for peripheral nerve repair
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注册号:

Registration number:

ChiCTR2000033324 

最近更新日期:

Date of Last Refreshed on:

2020-05-28 

注册时间:

Date of Registration:

2020-05-28 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

脱细胞神经基质修复膜用于周围神经修复的前瞻性、随机、单盲、平行对照的临床试验 

Public title:

Decellular neuromatrix repair membranes for prospective, randomized, single-blind, parallel controlled trial for peripheral nerve repair 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脱细胞神经基质修复膜用于周围神经修复的前瞻性、随机、单盲、平行对照的临床试验 

Scientific title:

Decellular neuromatrix repair membranes for prospective, randomized, single-blind, parallel controlled trial for peripheral nerve repair 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

任孝敏 

研究负责人:

陈山林 

Applicant:

Xiaomin Ren 

Study leader:

Shanlin Chen 

申请注册联系人电话:

Applicant telephone:

+86 13853541032 

研究负责人电话:

Study leader's telephone:

+86 15063831673 

申请注册联系人传真 :

Applicant Fax:

+86 0535-6399996 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

renxiaomin@ytjunxiu.com 

研究负责人电子邮件:

Study leader's E-mail:

ptp1673@dingtalk.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.ytjunxiu.com/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

山东省烟台市经济技术开发区珠江路32号 

研究负责人通讯地址:

北京市西城区新街口东街31号 

Applicant address:

32 Zhujiang Road, Economic and Technological Development Zone, Yantai City, Shandong Province 

Study leader's address:

31 East Xinjiekou Street, Xicheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

264006 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

山东隽秀生物科技股份有限公司 

Applicant's institution:

Shandong Junxiu Bio-Tech Co., Ltd. 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

(2016年)临审第(160518-088续1)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

吉林大学第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Jilin University First Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-12-14 

伦理委员会联系人:

赵丽媛 

Contact Name of the ethic committee:

Liyuan Zhao 

伦理委员会联系地址:

吉林省长春市新民大街71号 

Contact Address of the ethic committee:

71 Xinmin Street, Chaoyang District, Changchun, Jilin, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

吉林大学第一医院 

Primary sponsor:

Jilin University First Hospital 

研究实施负责(组长)单位地址:

吉林省长春市朝阳区新民大街71号 

Primary sponsor's address:

71 Xinmin Street, Chaoyang District, Changchun, Jilin, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东

市(区县):

烟台

Country:

China

Province:

Shandong

City:

Yantai

单位(医院):

山东隽秀生物科技股份有限公司

具体地址:

山东省烟台市经济技术开发区珠江路32号

Institution
hospital:

Shandong Junxiu Bio-Tech Co., Ltd.

Address:

32 Zhujiang Road, Economic and Technological Development Zone, Yantai City, Shandong Province

经费或物资来源:

山东隽秀生物科技股份有限公司 

Source(s) of funding:

Shandong Junxiu Bio-Tech Co., Ltd. 

研究疾病:

周围神经损伤 

Target disease:

Peripheral nerve injury 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

对用于修复周围神经损伤的脱细胞神经基质修复膜进行有效性和安全性评价。 

Objectives of Study:

Effectiveness and safety evaluation of decellular neuromatrix repair membranes used to repair peripheral nerve injure. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.年龄18-70岁患者,男女不限; 2.急性及亚急性外周神经创伤者; 3.亚急性外周神经创伤在3个月内的患者; 4.损伤神经修复长度小于2cm。 

Inclusion criteria

1. Aged 18-70 years men and women; 2. Acute and subacute peripheral nerve trauma; 3. Subacute peripheral nerve trauma in patients within 3 months; 4. Damage nerve repair length is less than 2cm. 

排除标准:

1.无法或不耐受手术治疗的患者; 2.有糖尿病史或严重过敏史患者: 3.患有自身免疫系统疾病或其他严重躯体疾病,可能影响本次研究的患者; 4.患有精神系统疾病,无自主行为能力; 5.多发复合神经严重损伤者: 6.妊娠、哺乳期女性患者 7.在近期3个月内参加其他临床研究的患者 8.研究者认为不宜继续进行本临床试验研究。 

Exclusion criteria:

1. Patients who are unable or unable to tolerate surgical treatment; 2. Patients with a history of diabetes or severe allergies; 3. Patients with autoimmune system diseases or other serious physical diseases that may affect the study; 4. suffering from mental system disease, no ability to act autonomously; 5. Multiple compound nerve severe injury; 6. Pregnant, baby-stage female patients; 7. Patients who have participated in other clinical studies in the last 3 months; 8. Researchers don't think it's appropriate to continue this clinical trial. 

研究实施时间:

Study execute time:

From2017-02-11To 2018-05-29 

干预措施:

Interventions:

组别:

试验组

样本量:

60

Group:

Experimental group

Sample size:

干预措施:

神经吻合后用神经修复膜包裹

干预措施代码:

Intervention:

After the nerve is anastomosed, it is wrapped with the nerve repair membrane

Intervention code:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

神经吻合后用神经鞘管包裹

干预措施代码:

Intervention:

After the nerve is anastomosed, it is wrapped with a nerve sheath

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

北京市 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京积水潭医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Jishuitan Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

长春 

Country:

China 

Province:

Jilin 

City:

Changchun 

单位(医院):

吉林大学第一医院 

单位级别:

三甲医院 

Institution
hospital:

Jilin University First Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

烟台 

Country:

China 

Province:

Shandong 

City:

Yantai 

单位(医院):

烟台毓璜顶医院 

单位级别:

三甲医院 

Institution
hospital:

Yantai Yuhuangding Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

感觉神经功能恢复优良率

指标类型:

主要指标 

Outcome:

Excellent and good rate of sensory nerve function recovery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

伤口愈合情况

指标类型:

次要指标 

Outcome:

Wound healing

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

手术前,所有受试者均需要签署知情同意书,临床试验将采取分段均衡随机法,受试者根据手术日期的先后顺序进行随机,通过打开随机信封对病人随机分组,根据随机号,确定患者具体进入试验组还是对照组。

Randomization Procedure (please state who generates the random number sequence and by what method):

Before surgery, all subjects are required to sign an informed consent form, clinical trials will take a segmented equilibrium random method, subjects according to the sequence of the date of surgery randomized, by opening random envelopes to the patient random grouping, according to the random number, to determ

盲法:

单盲

Blinding:

Single blind

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

文章发表

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

article published

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

临床试验机构保存原始记录、病例记录表等数据至试验结束后十年,申办者保存临床试验资料至无该医疗器械使用时。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The clinical trail insitution keep the original records, case records and other data to after ten years of off-test , the sponsor keep clinical trial data to without the medical equipment use.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-05-28
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